89bio initiates Phase 3 ENLIGHTEN-Fibrosis trial of pegozafermin

89bio announced the initiation of its Phase 3 ENLIGHTEN Program evaluating the efficacy and safety of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis, formerly known as nonalcoholic steatohepatitis. ENLIGHTEN-Fibrosis, the first of two Phase 3 trials in the program, has initiated and is evaluating non-cirrhotic MASH patients with fibrosis stage F2-F3. ENLIGHTEN-Fibrosis is a global Phase 3, randomized, double-blind, placebo-controlled trial of pegozafermin for the treatment of patients with biopsy-confirmed non-cirrhotic MASH. Approximately 1,000 patients are expected to be randomized in a 1:1:1 ratio to receive either 30mg of pegozafermin administered weekly, 44mg administered every two weeks, or placebo. The co-primary endpoints are a one-point or greater improvement in fibrosis with no worsening of MASH, and MASH resolution with no worsening of fibrosis. The co-primary endpoints will be assessed at week 52 and are intended to support a filing for accelerated approval in the U.S. and conditional approval in Europe in non-cirrhotic patients. Patients are expected to continue to be treated beyond the 52-week assessment through outcomes to support full approval. Key secondary endpoints include additional histological endpoints, noninvasive tests and metabolic and lipid assessments. The trial is designed to employ a three-panel consensus biopsy reading methodology, which was successfully utilized in the ENLIVEN trial. Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.